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Effects on fertility

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C9-14 aliphatics (2-25% aromatic) hydrocarbon fluids were examined for reproductive toxicity in a reproduction / developmental toxicity screening test (OECD TG 421).  C9-14 aliphatics (2-25% aromatic) hydrocarbon fluids were administered by inhalation at a dose of 0,100, and 300 ppm to groups of rats. It was concluded that C9-14 aliphatics (2-25% aromatic) hydrocarbon fluids did not induce reproductive toxicity in the offspring or in the parental animals. Therefore, the NOAEL was determined to be >=300 ppm (1720 mg/m3).

C9-C14 aliphatic, < 2% aromatic hydrocarbon fluids were examined for reproductive toxicity in a 28 day combined repeated dose toxicity study with the reproduction / developmental toxicity screening test (OECD TG 422).  C9-C14 aliphatic, < 2% aromatic hydrocarbon fluids were administered oral gavage at a dose of 0, 25, 150, or 1000 mg/kg/day to groups of Sprague-Dawley rats. It was concluded that C9-C14 aliphatic, < 2% aromatic hydrocarbon fluids did not induce reproductive toxicity in the parental animals and no effects on the endocrine system were observed.  Therefore, the NOAEL was determined to be >=1000 mg/kg bw/day. 

 

C9-C14 aliphatic, < 2% aromatic hydrocarbon fluids were examined in a reproduction / developmental toxicity screening test (OECD TG 421).  C9-C14 aliphatic, < 2% aromatic hydrocarbon fluids were administered by oral gavage at a dose of 0 (vehicle), 100, 300, 1000 mg/kg/day to groups of Sprague-Dawley rats. It was concluded that C9-C14 aliphatic, < 2% aromatic hydrocarbon fluids did not induce reproductive toxicity in the parental animals and no effects on the endocrine system were observed.  Therefore, the NOAEL was determined to be >=1000 mg/kg bw/day. 

In a first study male rats were given 0, 750, 1500 or 3000 mg/kg neat JP-8 daily by gavage for 70 days prior to mating with naive females to assess fertility and sperm parameters. After 70 days of dosing, body weights in the 3000 mg/kg group were over 30% lower than control weights. There were no significant changes for pregnancy rate, gestation length or sperm parameters as compared to control values. In the second study female rats were dosed with neat JP-8 (0, 325, 750, 1500 mg/kg) daily by gavage for a total of 21 weeks (90-day plus mating with naive males, gestation and lactation). In the reproductive and fertility segment, there were no statistically significant changes from control values for gestation length, pregnancy rate and number of pups per litter.

In a two generation study, rats were exposed to vapor recovery unit gasoline (volatile fraction of formulated gasoline) by inhalation at target concentrations of 5000, 10 000, and 20 000 mg/m3. There were no treatment-related clinical or systemic effects in the parental animals, and no microscopic changes other than hyaline droplet nephropathy in the kidneys of the male rats. None of the reproductive parameters were affected, and there were no deleterious effects on offspring survival and growth. The potential for endocrine modulation was also assessed by analysis of sperm count and quality as well as time to onset of developmental landmarks. No toxicologically important differences were found.

Based on these studies, C13-C16, n-alkanes, isoalkanes, cyclics, <0.03% aromatics are not expected to be reproductive toxicants.


Short description of key information:
Reproduction / Developmental Toxicity Screening Test (OECD TG 421) on C9-14 aliphatics (2-25% aromatic) - Inhalation Administration - The NOAEL for developmental toxicity was >=300 ppm (1720 mg/m3).

Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test (OECD TG 422) on C9-14 aliphatics (<2% aromatic) – Oral Administration - The NOAEL for developmental toxicity was 1000 mg/kg/day and the NOAEL for reproductive toxicity was 1000 mg/kg/day.
Reproduction / Developmental Toxicity Screening Test (OECD TG 421) on C9-14 aliphatics (<2% aromatic) - Oral Administration - The NOAEL for developmental toxicity was 1000 mg/kg/day and the NOAEL for reproductive toxicity was 1000 mg/kg/day.

Reproduction study (equivalent to OECD TG 415) on JP-8 jet fuel - Oral Administration - no statistically significant changes from control values for gestation length, pregnancy rate and number of pups per litter.

Two-generation study (equivalent to OECD TG 416) on vapor recovery unit gasoline - Inhalation exposure - None of the reproductive parameters affected, no deleterious effects on offspring survival and growth, no effects on sperm parameters and quality.

Effects on developmental toxicity

Description of key information
One developmental study was available on C16-C20 n-alkanes, isoalkanes, cyclics, <2% aromatics showing a NOAEL>1000 mg/kg/day for both maternal and developmental toxicity.
Effect on developmental toxicity: via oral route
Dose descriptor:
NOAEL
1 000 mg/kg bw/day
Additional information

One developmental study was available in rats orally exposed to C16-C20 n-alkanes, isoalkanes, cyclics, <2% aromatics showing a NOAEL>1000 mg/kg/day for both maternal and developmental toxicity.

Justification for classification or non-classification

These findings do not warrant the classification of C13-C16, n-alkanes, isoalkanes, cyclics, <0.03% aromatics as teratogenic under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP) or under the Directive 67/548/EEC for dangerous substances.

Additional information